The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.

Device Description

The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.

AI/ML Overview

The provided text describes the VORTRAN® Cuff Inflator (VCI) and its substantial equivalence determination by the FDA. However, it does not detail a study that defines acceptance criteria and then proves the device meets those criteria in the way typically seen for AI/ML-driven medical devices (e.g., involving AI model performance metrics like sensitivity, specificity, AUC).

This document is a 510(k) summary for a mechanical device, a cuff inflator, not an AI/ML-driven device. Therefore, many of the requested criteria in your prompt (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone AI performance) are not applicable to the information provided in this document.

The "Performance Data" section (Section VIII) states: "Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks. The performance testing includes a comparison between the VORTRAN® Cuff Inflator (VCI) and its predicate and reference devices, Posey Cufflator and Hospitech AG Cuffill."

Based solely on the provided document, here's an attempt to answer your questions, acknowledging the limitations for a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document provides "Pressure Accuracy and Range" as key performance characteristics. While not explicitly stated as "acceptance criteria" with pass/fail thresholds in the provided text, these are the performance targets the new device aims to match or be equivalent to.

Acceptance Criteria (Inferred from Predicate/Reference)	VORTRAN® Cuff Inflator (VCI) Reported Performance
Pressure Range: Similar to 0-120 cm-H2O (Predicate) or 0-99 cm-H2O (Reference)	0-60 cm-H2O
Accuracy of Cuff Pressure Measurement: Similar to ± 2 cm-H2O (Predicate/Reference) or ± 5 cm-H2O (Reference)	± 3 cm-H2O within 20 – 40 cm-H2O
Inflation Function: Comparable to predicate's bellows pump method	Manually press bellows pump
Deflation Function: Comparable to predicate's air vent button method	Manually press air vent button
Absence of Leaks: Demonstrated during testing	Tested (Implied to be acceptable)

Note: The document states for "Pressure Range": "(1) range has no significant difference, in comparison to its predicate or reference devices, and does not raise different questions of safety and effectiveness." This indicates the 0-60 cm-H2O range was deemed acceptable relative to the predicate/reference devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the document. The performance testing is described generally ("Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks.").
Data Provenance: Not specified. Given it's a technical performance test, it's likely lab-based and conducted by the manufacturer.
Retrospective/Prospective: Not applicable in the context of device performance testing in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. The ground truth for manometer accuracy, inflation/deflation function, and leak absence would be established by calibrated instruments and engineering measurements, not human expert consensus, for a mechanical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a human-reader study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done, as this is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical device. Its performance is its standalone performance. There is no "algorithm" in the AI sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance characteristics mentioned (manometer accuracy, inflation/deflation, leaks), the ground truth would be established by calibrated reference standards and engineering measurements. For example, manometer accuracy would be verified against a highly accurate master pressure gauge.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 25, 2018

VORTRAN Medical Technology 1, Inc. James Lee Executive Vice President & COO 21 Goldenland Court #100 Sacramento, California 95834

Re: K173914

Trade/Device Name: VORTRAN Cuff Inflator (VCI) Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: April 13, 2018 Received: April 18, 2018

Dear James Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173914

Device Name

VORTRAN® Cuff Inflator (VCI)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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I. SUBMITTER

VORTRAN Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 USA

Phone: (800) 434-4034 Fax: (916) 648-9751

Contact Person: James Lee Date Prepared: May 25, 2018

II. DEVICE

Name of Device: VORTRAN® Cuff Inflator (VCI) Common or Usual Name: Endotracheal cuff pressure regulator Classification Name: Cuff, Tracheal Tube, Inflatable Regulation Number: 21 CFR 868.5750 Regulatory Class: II Product Code: BSK Classification Advisory Committee: Anesthesiology Review Advisory Committee: Anesthesiology

III. PREDICATE AND REFERENCE DEVICE

K912723	Posey Cufflator (Predicate Device)
K122721	Hospitech AG Cuffill (Reference Device)
K142103	Teleflex Medical CUFF PILOT, SURE SEAL (Reference Device)
K153733	VORTRAN® Manometer (Reference Device - For Material Compatibility Only)
K041473	VORTRAN® Automatic Resuscitator (VAR-Plus) (Reference Device - For Material Compatibility Only)

DEVICE DESCRIPTION IV.

The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.

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510(k) Summary – VORTRAN® Cuff Inflator (VCI)

K173914/S002

INDICATIONS FOR USE V.

The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes. Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.

INTENDED POPULATION VI.

Intubated patients

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VII. WITH THE PREDICATE DEVICE

The tables below show the technological differences and similarities of our VORTRAN® Cuff Inflator (VCI) compared to the predicate devices.

	NEW DEVICE	PREDICATE DEVICE	REFERENCE DEVICE
Device Name	VORTRAN® Cuff Inflator (VCI)	Posey Cufflator	Hospitech AG Cuffill
510(k) Number	K173914/S002	K912723	K122721
Technology	Inflation - Bellows pumpMeasurement - Mechanical gaugeSame as predicate device	Inflation - Bellows pumpMeasurement - Mechanical gauge	Inflation - Syringe plungerMeasurement - Electronic PressureSensor
Method of InflatingCuff	Manually press bellows pumpSame as predicate device	Manually press bellows pump	Manually press syringe plunger
Method ofDeflating Cuff	Manually press air vent buttonSame as predicate device	Manually press air vent button	Manually pull out syringe plunger
Attaches to CuffInflation Pilot	Via male Luer fittingSame as predicate devices	Via male Luer fitting	Via male Luer fitting
Types of airways towhich it can beused	Endotracheal tubes, tracheostomytubes, and Laryngeal Mask Airways(LMAs)Same as predicate devices	Endotracheal tubes or trachealtubes	Endotracheal tubes, tracheotomy tubes,and Laryngeal Mask Airways (LMAs)

Operational Characteristics:

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510(k) Summary – VORTRAN® Cuff Inflator (VCI)

K173914/S002

Pressure Accuracy and Range:

	NEWDEVICE	PREDICATEDEVICE	REFERENCEDEVICE	REFERENCEDEVICE
Device Name	VORTRAN® Cuff Inflator (VCI)	Posey Cufflator	Hospitech AGCuffill	SureSeal™ withCuff Pilot™
510(k) Number	K173914/S002	K912723	K122721	K142103
Pressure Range of Device (1)	0-60 cm-H2O	0-120 cm-H2O	0-99 cm-H2O	0-80 cm-H2O
Accuracy of Cuff PressureMeasurement (1)	± 3 cm-H2O within the typicaloperating range of20 – 40 cm-H2O	± 2 cm-H2O	± 2 cm-H2O	± 5 cm-H2O

(1) range has no significant difference, in comparison to its predicate or reference devices, and does not raise different questions of safety and effectiveness.

Physical Characteristics:

	NEW DEVICE	PREDICATE DEVICE	REFERENCE DEVICE
Device Name	VORTRAN® Cuff Inflator (VCI)	Posey Cufflator	Hospitech AG Cuffill
510(k) Number	K173914/S002	K912723	K122721
Size	3 in. x 2 in. x 1.8 in.	None specified	Length: 7.87 in.Diameter (ID): 0.59 in.

Material of Construction:

The VORTRAN® Cuff Inflator (VCI) uses the same materials as predicate devices manufactured by VORTRAN Medical. The following table lists the component name, their material, cleared device name, and 510k Number/Date.

	NEW DEVICE	REFERENCE DEVICEFOR MATERIAL ONLY	REFERENCE DEVICEFOR MATERIAL ONLY
Device Name	VORTRAN® Cuff Inflator (VCI)	VORTRAN® Manometer	VORTRAN® AutomaticResuscitator (VAR-Plus)
510(k) Number	K173914/S002	K153733	K041473
Date SE Decision	N/A	September 16, 2016	July 15, 2004
All Plastic Components: Body, PumpEnclosure, Pump Seal Disk, PumpSpring Cap, Pump Lock Ring,Release Enclosure, Release SealDisc, Release Spring Cap	PolycarbSame as reference device(VORTRAN® Manometer)	Manometer Top, Gear End Plate,Tee Connector, DiaphragmSupport Disk, and VerticalConnection:Polycarb	N/A
All Rubber Components:Pump, Quad Rings	SiliconeSame as reference devices	Diaphragm:Silicone	Diaphragm:Silicone
All Springs:Pump Spring, Release Spring	Stainless SteelSame as reference device(VORTRAN® AutomaticResuscitator VAR-Plus)	N/A	Internal Springs:Stainless Steel
Manometer Assembly:	Entire assembly identical toreference device (VORTRAN®Manometer)	All materials and componentscleared under 510(k) No.K153733	N/A

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VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing .

Neither the VORTRAN® Cuff Inflator (VCI), nor the air pumped from it, comes in direct or indirect contact with the patient or the user. Therefore, as per ISO 10993-1, there is no requirement for the VORTRAN® Cuff Inflator (VCI) components or its materials to be tested for biocompatibility.

Animal Study ●
N/A
Clinical Studies None

. Non-Clinical Performance Data

Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks. The performance testing includes a comparison between the VORTRAN® Cuff Inflator (VCI) and its predicate and reference devices, Posey Cufflator and Hospitech AG Cuffill.

● Clinical Application

The VORTRAN® Cuff Inflator (VCI) connects to cuffed tubes (via a Luer fitting), which are used in applications in which a patient is intubated.

Compliance with Performance Standards ● None

CONCLUSIONS IX.

The VORTRAN® Cuff Inflator (VCI) is substantially equivalent to predicate devices: Posey Cufflator (primary) and reference devices: Hospitech AG Cuffill, VORTRAN® Manometer (material only), and VORTRAN® Automatic Resuscitator (VAR-Plus) - (material only). The VORTRAN® Cuff Inflator (VCI) is concluded to not raise any different questions of safety and effectiveness in comparison to its predicate devices.

Regulation Number and Section

§ 868.5750 Inflatable tracheal tube cuff.

(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).